Home NDC 69315-402 VARENICLINE TARTRATE
Product NDC 69315-402
11-digit product format 693150402
Labeler code 69315
Product ID 69315-402_cd15d74e-92d3-4bf0-8c76-a01f9190b172
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VARENICLINE TARTRATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Leading Pharma, LLC
Application ANDA217151
Marketing category ANDA
Marketing start 2023-10-01
Substance VARENICLINE TARTRATE
Active strength .5 mg/561
Pharmacologic classes Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217151-001 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 A217151-002 VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217151-001 VARENICLINE TARTRATE EQ 0.5MG BASE TABLET / ORAL AB 2023-07-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217151-002 VARENICLINE TARTRATE EQ 1MG BASE TABLET / ORAL AB 2023-07-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base VARENICLINE TARTRATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARENICLINE TARTRATE .5 mg/561
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 82269ASB48 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 636671 Internal RxNorm lookup 636676 Internal RxNorm lookup 749289 Internal RxNorm lookup 749788 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69315-402-56 VARENICLINE TARTRATE 56 in 1 BOTTLE TABLET, FILM COATED 56 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-402 VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE TARTRATE KIT [LEADING PHARMA, LLC] 7 Current NDC, 1 package rows 20241129_fdb36cfa-d20a-4fd9-b994-a5d16e4bb438.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69315-402-56 69315040256 56 TABLET, FILM COATED in 1 BOTTLE (69315-402-56) 2023-10-01 No No Current